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FDA 510(k)

TIPCAM1 Rubina Video Endoscope System

K-Number: K201526 · 2020-11-20

ApplicantKarl Storz Endoscopy America
Decision Date2020-11-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TIPCAM1 Rubina Video Endoscope System is a medical device manufactured by Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2020-11-20 under approval number K201526. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIPCAM1 Rubina Video Endoscope System?

TIPCAM1 Rubina Video Endoscope System is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Karl Storz Endoscopy America. The 510(k) number is K201526.

When was TIPCAM1 Rubina Video Endoscope System approved by the FDA?

TIPCAM1 Rubina Video Endoscope System received FDA 510(k) clearance on 2020-11-20, under approval number K201526.

What company makes TIPCAM1 Rubina Video Endoscope System?

TIPCAM1 Rubina Video Endoscope System is manufactured by Karl Storz Endoscopy America.

What is the FDA product code for TIPCAM1 Rubina Video Endoscope System?

The FDA product code for TIPCAM1 Rubina Video Endoscope System is GCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Karl Storz Endoscopy America

K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S) K212695KARL STORZ ICG Imaging System K201001Modulith SLX-F2 K212458Flexible Video-Uretero-Renoscope SSU System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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